FDA Adverse Event
Injury
Summary report: N
IDENTITY XL DR
MDR report key: 1896265
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05289
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 6, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACK-UP MODE AND THAT THE BATTERY WAS DEPLETED. THE BATTERY WAS AT END-OF-LIFE (EOL). AFTER REPLACING THE BATTERY, NORMAL FUNCTION ENSUED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTER-ROGATED AND WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5376 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Required Intervention |